PainPhase 2/3NCT02847013
The Use of Liposomal Bupivacaine in TAP Blocks for Women Undergoing Cesarean Section
A Phase 2/3 study testing TAP block w Liposomal bupivacaine and TAP block w normal saline in people with Pain, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
This present investigation aims to determine whether a transversus abdominous plane(TAP) block, utilizing liposomal bupivacaine (Exparel), at the conclusion of a cesarean section decreases post-operative pain. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- TAP block w Liposomal bupivacaine and TAP block w normal saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento 17 Dec 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients >18 years of age
- Scheduled cesarean section with or without bilateral tubal ligation
- Planned performance of a Pfannenstiel incision
- Patients are schedule to have a cesarean section with a member of the Women's Health or Maternal and Fetal Medicine Departments at Penn State University Hershey S. Medical Center
Who cannot join
- History of opioid use
- History of chronic pain syndrome
- Use of general anesthesia during cesarean delivery
- Postoperative SICU admission
- Postpartum hemorrhage (defined as an Estimated Blood Loss of greater then 1,000mL upon completion of the cesarean section)
Trial locations and contacts
1 site in 1 country.
United States1 site
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
About this study
This present investigation aims to determine whether a transversus abdominous plane(TAP) block, utilizing liposomal bupivacaine (Exparel), at the conclusion of a cesarean section decreases post-operative pain. The hypothesis is that performance of the TAP block with liposomal bupivacaine will decrease post-operative narcotic use.
- Conditions
- Pain
- Being tested
- TAP block w Liposomal bupivacaine, TAP block w normal saline
- Keywords
- Postcesarean Section, Postoperative
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP block w Liposomal bupivacaineDrug
Also called Exparel
TAP block w Liposomal bupivacaine diluted to 0.66% (20 mLs)
TAP block w normal salineProcedure or surgery
TAP block w normal saline -preservative free 0.9% sodium chloride (20mLs)
| Study group | Role | What they receive |
|---|---|---|
| Placebo- Tap block w normal saline | Placebo comparator | After completion of surgery with closer of skin incision a TAP block will be performed. On confirmation of entering the fascial plane, 20cc of Normal saline will be injected after negative aspiration. That will complete the intervention. 20 patients will be in this arm Receives: Procedure: TAP block w normal saline |
| Intervention-Tap block w Liposomal bupivacaine | Experimental | After completion of surgery w closure of skin incision a TAP block will be performed. On confirmation of entering the fascial plane, Liposomal bupivacaine 0.33% (10 ml diluted to 20 ml using sterile normal saline) will be injected after negative aspiration. That will complete the intervention. 20 patients will be in this arm Receives: Drug: TAP block w Liposomal bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative narcotic use
Patient use of standard postoperative narcotics (percocet) will be measured.
Measured: initial 48 hours postoperatively
Secondary outcomes (1)
Subjective pain scores using 1-10 VAS system
Subjective pain scores using 1-10 VAS system will be measured
Measured: initial 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Primary completion17 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaimey M. Pauli, MD, Milton S. Hershey Medical Center
- Investigators
- Jaimey Pauli, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847013
- Sponsor's protocol ID
- 00005133
- Status last verified
- Jan 2020
- First submitted
- 25 Jul 2016
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Liposomal Bupivacaine in TAP Blocks for Women Undergoing Cesarean Section
- ClinicalTrials.gov ID
- NCT02847013
- Acronym / sponsor ID
- 00005133
- Conditions
- Pain
- Keywords
- Postcesarean Section, Postoperative
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Primary completion
- 17 Dec 2019 (actual)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This present investigation aims to determine whether a transversus abdominous plane(TAP) block, utilizing liposomal bupivacaine (Exparel), at the conclusion of a cesarean section decreases post-operative pain. The hypothesis is that performance of the TAP block with liposomal bupivacaine will decrease post-operative narcotic use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo- Tap block w normal saline | Placebo comparator | Procedure: TAP block w normal salineAfter completion of surgery with closer of skin incision a TAP block will be performed. On confirmation of entering the fascial plane, 20cc of Normal saline will be injected after negative aspiration. That will complete the intervention. 20 patients will be in this arm |
| Intervention-Tap block w Liposomal bupivacaine | Experimental | Drug: TAP block w Liposomal bupivacaineAfter completion of surgery w closure of skin incision a TAP block will be performed. On confirmation of entering the fascial plane, Liposomal bupivacaine 0.33% (10 ml diluted to 20 ml using sterile normal saline) will be injected after negative aspiration. That will complete the intervention. 20 patients will be in this arm |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients >18 years of age
- Scheduled cesarean section with or without bilateral tubal ligation
- Planned performance of a Pfannenstiel incision
- Patients are schedule to have a cesarean section with a member of the Women's Health or Maternal and Fetal Medicine Departments at Penn State University Hershey S. Medical Center
Key exclusion criteria (5 listed)
- History of opioid use
- History of chronic pain syndrome
- Use of general anesthesia during cesarean delivery
- Postoperative SICU admission
- Postpartum hemorrhage (defined as an Estimated Blood Loss of greater then 1,000mL upon completion of the cesarean section)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAP block w Liposomal bupivacaineAlso: ExparelTAP block w Liposomal bupivacaine diluted to 0.66% (20 mLs) | Drug | Intervention-Tap block w Liposomal bupivacaine |
| TAP block w normal salineTAP block w normal saline -preservative free 0.9% sodium chloride (20mLs) | Procedure or surgery | Placebo- Tap block w normal saline |
Primary outcome
Postoperative narcotic use
Time frame: initial 48 hours postoperatively
Patient use of standard postoperative narcotics (percocet) will be measured.
1 secondary outcome
Subjective pain scores using 1-10 VAS system
Time frame: initial 48 hours postoperatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaimey Pauli, MD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TAP block w Liposomal bupivacaine and TAP block w normal saline in people with Pain, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative narcotic use (time frame: initial 48 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.